The following data is part of a premarket notification filed by Stan-pak Ent. with the FDA for Vag Packing.
Device ID | K820096 |
510k Number | K820096 |
Device Name: | VAG PACKING |
Classification | Dressing, Wound, Drug |
Applicant | STAN-PAK ENT. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-13 |
Decision Date | 1982-02-04 |